Comparison Between Oxomemazine, Guaifenesin and Potassium Iodate Versus Guaifenesin Monotherapy in Acute Cough Treatment

Phase 3

Completed

• Conditions: Cough
• Interventions: Drug: Syrup of guaifenesin; Drug: Syrup of oxomemazine, guaifenesin and potassium iodate

• Registration Number: NCT01257243
• Lead Sponsor: EMS

Brief Summary

The purpose of this study is evaluate if efficacy of a combination dose of oxomemazine, guaifenesin and potassium iodate is superior than guaifenesin monotherapy in acute cough treatment.

Detailed Description

STUDY DESIGN

* Open-label, superiority, prospective, parallel group, intent to treat trial

* Experiment duration: 7 days

* 3 visits (days 1, 2 and 7)

* Reduction cough symptoms

* Adverse events evaluation

Study Timeline

• Study First Submitted: 2010-12-08
• Study First Submitted QC: 2010-12-08
• Study First Posted: 2010-12-09
• Study Start: 2012-10-01
• Primary Completion: 2013-09-30
• Study Completion: 2013-10-25
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

1. Patients must be able to understand the study procedures agree to participate and give written consent.
2. Patients with productive cough as result an acute URTI (i.e., cold or flu) or allergic cough in the last 10 day.
3. Cough score superior to 3.

Exclusion Criteria

1. Pregnancy or risk of pregnancy.
2. Lactation.
3. Fever above 38º C.
4. Patients with bacterial infections of the upper respiratory tract.
5. Any pathology or past medical condition that can interfere with this protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DRUG 2	Syrup of guaifenesin	Syrup of guaifenesin
DRUG 1	Syrup of oxomemazine, guaifenesin and potassium iodate	Syrup of oxomemazine, guaifenesin and potassium iodate

Primary Outcome Measures

Name	Time	Method
Reduction/improvement of cough symptoms	DAY 7	The reduction of cough symptoms will be evaluated by comparative score index basal and final score

Secondary Outcome Measures

Name	Time	Method
Tolerance	DAY 7	Adverse events will be collected and followed in order to evaluate safety and tolerability

Trial Locations

Locations (1)

Beneficência Nipo Brasileira de São Paulo - Hospital Nipo Brasileiro; 🇧🇷 São Paulo, Brazil